Prosecution Insights
Last updated: July 17, 2026
Application No. 18/592,253

SYSTEMS, DEVICES, AND METHODS FOR NON-INVASIVE IMAGE-BASED PLAQUE ANALYSIS AND RISK DETERMINATION

Non-Final OA §112
Filed
Feb 29, 2024
Priority
Nov 14, 2022 — provisional 63/383,632 +17 more
Examiner
RAYMOND, KEITH MICHAEL
Art Unit
3798
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Cleerly Inc.
OA Round
3 (Non-Final)
55%
Grant Probability
Moderate
3-4
OA Rounds
1y 4m
Est. Remaining
77%
With Interview

Examiner Intelligence

Grants 55% of resolved cases
55%
Career Allowance Rate
224 granted / 405 resolved
-14.7% vs TC avg
Strong +22% interview lift
Without
With
+21.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
12 currently pending
Career history
416
Total Applications
across all art units

Statute-Specific Performance

§101
0.3%
-39.7% vs TC avg
§103
89.4%
+49.4% vs TC avg
§102
1.8%
-38.2% vs TC avg
§112
7.7%
-32.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 405 resolved cases

Office Action

§112
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-7 and 9-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 states the following limitations that have are not mentioned in the specification, claims, or drawings as originally filed: “using a single image acquisition protocol” (lines 3-4) and “wherein the risk assessment of coronary artery disease…..aortic disease……pneumonia, and…..pulmonary embolism are generated substantially concurrently from analyzing one or more portions of the one or more medical images obtained using the single image acquisition protocol”. There is no mention in the specification of these risk assessments being generated concurrently with each other in the originally filed application nor is there mention of taking all 4 from a single portion of an image (one or more portions) and it is unclear how all 4 of these can be determined by as single portion of an image. Further there is no mention of all 4 of the risk assessments being analyzed from a single image acquisition protocol. Claim 21 states “accessing cardiac and pulmonary data” along with additional analyzing steps of the risk assessment and hospital admission and discharge using an artificial intelligence algorithm. The processing of this data is not mentioned in the specification as originally filed. Applicant is asked to provide the specific support for this new claim in the specification. Additionally there is no written description of said algorithm or what it entails to achieve the risk assessment. Claims 2-7 and 9-21 depend from claim 1 and therefore inherit the 35 USC 112 deficiencies of their parent claim. The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-7 and 9-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 states wherein the risk assessment of coronary artery disease…..aortic disease……pneumonia, and…..pulmonary embolism are generated substantially concurrently from analyzing one or more portions of the one or more medical images obtained using the single image acquisition protocol”. It is unclear how it is possible to generate a risk assessment on all 4 of these portions of the body with a single portion of an image. Claims 2-7 and 9-21 depend from claim 1 and inherit the 35 USC deficiencies of their parent claim. Claim 21 provides for an artificial intelligence algorithm with no clear support in the specification as to how the algorithm operates. It is found to be indefinite as it is unclear what sort of process the algorithm utilizes to generate the risk assessments from the data or what the data includes of the patient. Allowable Subject Matter Claims 1-7 and 9-21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. The following is an examiner’s statement of reasons for allowance: Applicant’s arguments (pages 4-6) with regard to the combination of different prior art diagnostic techniques into a single concurrent assessment of risk of coronary artery disease, aortic disease, pulmonary embolism, and pneumonia from a single image acquisition protocol is not taught by any of the references and a combination of all of the references would not be obvious as they utilize different protocols and methods of risk assessment then the claimed invention is persuasive. Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.” Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keith Raymond whose telephone number is (571)270-1790. The examiner can normally be reached Monday-Friday 9AM - 5PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
Read full office action

Prosecution Timeline

Feb 29, 2024
Application Filed
Aug 27, 2025
Non-Final Rejection mailed — §112
Nov 26, 2025
Response Filed
Dec 23, 2025
Final Rejection mailed — §112
Mar 12, 2026
Request for Continued Examination
Apr 01, 2026
Response after Non-Final Action
Apr 21, 2026
Non-Final Rejection mailed — §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
55%
Grant Probability
77%
With Interview (+21.8%)
3y 9m (~1y 4m remaining)
Median Time to Grant
High
PTA Risk
Based on 405 resolved cases by this examiner. Grant probability derived from career allowance rate.

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